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Safety concerns about long-term bisphosphonate use have led investigators to assess the pros and cons of discontinuing treatment. In this double-blind extension study, industry-funded investigators randomized 1233 menopausal women with osteoporosis (mean age at extension study baseline, 76; mean prevalence of vertebral fracture, 61%) who had already received 3 annual doses of zoledronic acid (ZOL) to placebo or ZOL for 3 more years. Outcomes included incident morphometric vertebral fractures (MVF) found on thoracic x-rays taken at the end of the extension period, clinically reported nonvertebral fractures (NVF), and change in hip bone mineral density (BMD).
During the extension phase, overall rates of MVF and NVF were 4.6% and 8.0%, respecti…